U.S. FDA Registration & Labeling Compliance Assistance

Navigate the OTC Drug Registration Steps - from establishment registration to obtaining labeler code and OTC drug listing- and learn how to bring OTC products to the U.S. market.

Obtain the National Drug Code (NDC) Labeler code for your drug products by submitting a request in SPL format. FDA Listing Inc. can assist you as a U.S. agent in preparing and submitting the necessary files.

All drug color additives must be FDA approved for their specific intended use and formulation. Drug colors additives must be either FDA certified colors (on a batch basis), or exempted from FDA color certification. Batch Certification is a process by which FDA evaluates the composition of all colors used in drug formulation. To obtain the color additive batch certification, drug manufacturers must submit a sample of the color additive for each batch used in the product formulation along with the batch-specific documents. After proper examinations U.S. FDA will certify the color additive if the analysis of the batch sample meets the FDA requirements.